Last reviewed · How we verify
NCT03188445
Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.
Completed
Phase 4
Last updated 13 November 2020
What this trial tests
Phase 4 trial testing Iron Isomaltoside 1000 in Iron Deficiency Anemia of Pregnancy in 201 participants. Completed in 18 August 2020.
Timeline
11 July 2017
Primary endpoint
26 June 2020
26 June 2020
18 August 2020
Quick facts
| Lead sponsor | Pharmacosmos A/S |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 201 |
| Start date | 11 July 2017 |
| Primary completion | 26 June 2020 |
| Estimated completion | 18 August 2020 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Iron Isomaltoside 1000 — full drug profile →
- ferrous fumarate with ascorbic acid — full drug profile →
Conditions studied
- Iron Deficiency Anemia of Pregnancy — all drugs for Iron Deficiency Anemia of Pregnancy →
Sponsor
Pharmacosmos A/S — full company profile →
Who can join
18 and older, female only, with Iron Deficiency Anemia of Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial.
Hansen R, Sommer VM, Pinborg A, Krebs L, et al · · 2023 · cited 23× · PMID 36107229 · DOI 10.1007/s00404-022-06768-x -
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial.
Markova V, Hansen R, Thomsen LL, Pinborg A, et al · · 2020 · cited 5× · PMID 32843079 · DOI 10.1186/s13063-020-04637-z -
Incidence of adverse events in iron-deficient pregnant women and surgical patients undergoing intravenous iron treatment with ferric isomaltose or ferric carboxymaltose: A systematic review.
Heger D, Volkmann J, Weibel S, Stoevesandt J, et al · · 2026 · cited 1× · PMID 41623111 · DOI 10.1111/trf.70105 -
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial
Markova V, Hansen R, Thomsen LL, Pinborg AB, et al · · 2020 · DOI 10.21203/rs.2.20504/v1
Verify or expand the search:
- PubMed search for NCT03188445
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Iron Isomaltoside 1000
Trials testing the same drug.
- NCT05913414 — Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma · Phase 2 · recruiting
- NCT04505514 — Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia · Phase 4 · unknown
- NCT04061655 — Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion · EARLY_PHASE1 · completed
- NCT03662789 — Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients · Phase 2, PHASE3 · completed
- NCT03470649 — Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients · NA · completed
Other recruiting trials for Iron Deficiency Anemia of Pregnancy
Currently open trials in the same condition.
- NCT06875947 — EFFECTS of MORINGA OLEIFERA LEAF POWDERS on HEMATOLOGICAL PROFILES IN PREGNANT WOMEN WITH IRON DEFICIENCY ANAEMIA · NA · active not recruiting
- NCT06366698 — Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia · Phase 3 · recruiting
- NCT07083492 — Non-invasive Detection of Iron Deficiency in Obstetrics · recruiting
- NCT04008147 — Hepcidin and Glucose Metabolism · NA · recruiting
Other Pharmacosmos A/S trials
Trials by the same sponsor.
- NCT06929806 — Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chroni · Phase 3 · recruiting
- NCT05545202 — A Randomized, Comparative, Double-blind Trial of Pentaisomaltose and Dimethyl Sulphoxide for Cryoprotection of Hematopoi · Phase 4 · not yet recruiting
- NCT05874401 — Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan · Phase 4 · recruiting
- NCT05179226 — Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia · Phase 3 · recruiting
- NCT03466983 — A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxyma · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03188445 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pharmacosmos A/S
- Last refreshed: 13 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03188445.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing